Efficacy and Safety of GP40071 Compared to NovoRapid® Penfill® in Type 1 Diabetes Mellitus Patients

Geropharm

Status and phase

Completed

Phase 3

Conditions

Diabetes Mellitus, Type 1

Diabetes

Treatments

Drug: GP40071

Drug: NovoRapid® Penfill®

Study type

Interventional

Funder types

Industry

Identifiers

NCT04079413

GP40071-P4-31

Details and patient eligibility

About

This trial is a multi-center, open-label, randomized, parallel group trial in adult patients with T1DM comparing the efficacy and safety of GP40071 (insulin aspart, GEROPHARM) with that of NovoRapid®.

Enrollment

264 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Signed written consent
Diabetes mellitus type 1 for at least 12 months prior to screening
History of basis-bolus (multiple dose injection (MDI)) therapy in stable doses at least 30 days
Glycated hemoglobin (HbA1c) level of 7.1 to 12.0 % at screening (both values inclusive)
Body mass index (BMI) of 18.5 to 35 kg/m2 at screening (both values inclusive)
Subject is able and willing to comply with the requirements of the study protocol

Exclusion criteria

Contraindication to the use of insulin aspart
Insulin resistance over 1.5 U/kg insulin pro day
Change INN of insulin for 6 months prior to randomisation
History of treatment any biosimilar insulin for 6 months prior to randomisation (excl. GEROPHARM's insulins)
History of treatment any experimental drugs or medical devices for 3 months prior to randomisation
History of treatment insulin pump for 180 days prior to signed written consent or indication for use insulin pump
Presence of severe diabetes complications
History of severe hypoglycemia for 6 months prior to screening
History of 15 or more episodes mild hypoglycemia for 1 month prior to screening
History or presence of uncontrolled diabetes mellitus for 6 months prior to screening
History of administration of glucocorticoids (14 days or more) for 1 year prior to screening
Administration of any immunosuppressive drugs (Cyclosporine, Methotrexate, Rituximab, etc.)
History of vaccination for 6 months prior to randomisation
History of autoimmune disease, except vitiligo and controlled autoimmune polyglandular syndrome (APS) types 1-3, except adrenal insufficiency
History of unstable angina, myocardial infarction, severe arrhythmia, heart failure III or IV NYHA for 1 year prior to screening
History of stroke or TIA for 6 months prior to screening
History of hypersensitivity to any of the active or inactive ingredients of the insulin/insulin analogue preparations used in the trial, OR history of significant allergic drug reactions
Pregnant and breast-feeding women
Acute inflammation disease for 3 weeks prior to screening
Deviation of the laboratory results conducted during the screening:

Hemoglobin value < 9,0 g/dl; Hematocrit value < 30 %; ALT and AST value > 2 folds as high as maximal normal value; Serum bilirubin value > 1.5 folds as high as maximal normal value

History of hematological disorders that can affect the reliability of HbA1c estimation (hemoglobinopathies, hemolytic anemia, etc.)
Serious blood loss for 3 months prior to screening (blood donation, surgery procedure, etc.)
Incomplete recovery after surgery procedure
History of drug, alcohol abuse for 3 years prior to screening
Serological evidence of human immunodeficiency virus (HIV), hepatitis B (HbSAg), hepatitis C (HCVAb) or syphilis (Treponema pallidum) antibodies at screening
History of oncological disease during 5 years prior to screening
History of transplantation, except 3 months after corneal transplant
History or presence of a medical condition or disease that in the investigator's opinion would embarrass glycemic control and completion of the study
Inability follow to protocol